Method of treating HIV positive subjects

A method of lowering p24 (HIV) antigen to not more than 40 picograms/ml in an HIV positive subject by the administration of a therapeutically active composition is disclosed. The composition includes as an active pharmaceutical an extract of at least one plant of the Asphodelus genus and the tenuifolius species or the chemical equivalent thereof. The plant extract includes an aqueous extract of a woody stem, a root system, a plurality of loculicidal capsules, and a plurality of seeds. The plant extract is admixed with a pharmaceutically acceptable carrier such as water.

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Description

The subject matter, in its entirety, of U.S. Pat. No. 5,091,181 (issued Feb. 25, 1992) is incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates to a method for treating HIV positive subjects. More particularly, this invention relates to a method for treating HIV positive subjects wherein the composition combats the virus.

BACKGROUND OF THE INVENTION

To date, there are several widespread diseases that are often fatal and which generally involve a certain type of white blood cell that is responsible for orchestrating the immune system of the body. Among such diseases are adult T-Cell leukemia (ATL) and acquired immunodeficiency syndrome (AIDS). These diseases not only infect the same type of white blood cell, but further share another crucial feature in that they are all caused by a class of infectious agents known as retroviruses.

Retroviruses are viruses that cannot replicate without controlling and exploiting the biosynthetic apparatus of a cell for different purposes. Retroviruses consist of the genetic material of RNA and are capable of reversing the ordinary flow of genetic information (from DNA to RNA to proteins). Additionally, retroviruses carry an enzyme called reverse transcriptase which uses the viral RNA as a template for making DNA. The viral DNA integrates itself into the genome of the host wherein it remains latent until it is activated to make new virus particles. Much attention is being paid to the human immunodeficiency virus (HIV) retrovirus which causes AIDS due to its rapid transmission, progressive derangement of immune function, and high fatality rate.

It appears that the HIV retrovirus enters a cell by binding to a molecule known as the CD4 antigen. The CD4 antigen is found primarily on a specific set of white blood cells of the immune system called T4 lymphocytes or helper T-cells. Accordingly, HIV infection is characterized by the loss of these T-lymphocyte cells which causes a deterioration of the immune system.

The T-lymphocyte cell is crucial to the immune system in that, among other functions, it recognizes foreign antigens, markers, or infected cells, and helps to activate another set of lymphocyte white blood cells which multiply and produce antibodies that bind to infected cells. The T-lymphocyte cell further is capable of completely eliminating infected cells. Thus, the loss of T-lymphocyte cells not only seriously impairs the body's ability to fight most invaders, but also has a severe impact on the defenses against viruses, fungi, parasites, and certain bacteria.

In the case of AIDS and some forms of hepatitis and leukemia, it is the secondary infections which are the actual cause of death. My previous patent, U.S. Pat. No. 5,091,181 was directed to the need for treating such immune deficiency-causing diseases by means that would boost the suppressed lymphocyte levels and provide a defense against life-threatening secondary infections.

Presently, there is no known cure for AIDS. There are, however, various experimental drugs on the market, including an antiviral substance known as azidothymidine (AZT) which has been shown to prolong the lives of certain AIDS subjects. These drugs are, for the most part, extremely expensive and often difficult to obtain.

Thus, although there is no cure for AIDS, early intervention with antiretroviral therapy can substantially decrease the risk of opportunistic infections and may improve the survival of subjects with HIV infection. Accordingly, a procedure to detect the virus itself rather than the immune response to the virus is critical.

There are several known diagnostic techniques for detecting HIV infection in adults and children. One such diagnostic technique is the immune-complex-dissociated HIV p24 antigen assay which is a rapid, simple serologic test that may be used to diagnose HIV infection. The p24 antigen of human immunodeficiency virus type 1 (HIV-1) is sometimes detected before antibody (anti-HIV-1) is detectable in the serum of recently infected persons. This is because the p24 antigen is usually present in the circulation of the HIV-infected subject shortly after infection with HIV-1 and before the development of a humoral response. Thus, the HIV p24 antigen assay reveals the presence of circulating p24 antigen which appears to stimulate the often rapid development of the AIDS virus.

Accordingly, it is an object of the present invention to provide a method for treating HIV positive subjects to combat the virus.

A further object of the present invention is to provide a method for treating HIV positive subjects that is easily administered to the subject and which is relatively inexpensive.

Yet another object of the present invention is to provide a method for treating HIV positive subjects.

The objectives and advantages of the present invention are achieved by providing a method for treating HIV positive subjects by administering an effective amount of a therapeutically active composition to a subject. The composition used in the method has a medicinal application and has resulted in a negative reading for the p24 (HIV) antigen in a subject that initially tested positive for the p24 (HIV) antigen. Also, the composition used in the method maintained a negative reading for the p24 (HIV) antigen in a subject that initially tested negative for the p24 (HIV) antigen.

The foregoing composition used in the inventive method includes as an active pharmaceutical an extract of at least one edible plant or herb. Specifically, the herb is a Mediterranean and West Asiatic plant known as Asphodelus tenuifolius. The genus Asphodelus describes a hardy, herbaceous stemless plant having white, lily-like flowers in long racemes, fleshy fascicled roots and firm, linear, radical,.tufted leaves. It generally grows as a common weed in the above-cited locations.

More specifically, the composition derives from one species of asphodel, a purple-flowering variant of Asphodelus tenuifolius which occurs in Greece and Turkey. This identification is based on R. M. T. Dahlgren, et al's "The Families of Monocotyledons--Structure, Evolution and Taxonomy", Springer-Verlag, New York (1985).

Minor discrepancies of plant classification are often found between different botanists' works. Therefore, A. tenuifolius has been described as "identical" to A. microcarpus and A. aestivus by some classifiers of the plant (see Bailey, Standard Cyclopedia of Horticulture, Macmillan Co., New York, 1935), and alternatively as "allied to" A. Fistulosis by others (see Chittenden, Dictionary of Gardening, Clarendon Press Oxford, 1956). These species are closely related. Accordingly, it is expected that asphodel species other than A. tenuifolius will be identified which will yield an equally therapeutic composition.

My U.S. Pat. No. 5,091,181 is directed to providing a composition for increasing the white cell levels in subjects by use of an herbal composition. The composition used in that patent is the same as is used in this invention. However, I have also provided the additional composition of using a mixture of the herbal extract of U.S. Pat. No. 5,091,181 with a cortisone.

Thus, the inventive method herein involves treating HIV positive subjects with an extract derived from an edible plant known as Asphodelus tenuifolius or its chemical equivalent. The plant is collected in its dry form. A certain methodology has been developed for the extraction process (see U.S. Pat. No. 5,091,181). This methodology involves using the entire plant in the production of the extract, including the whole woody stem, the root system, the loculicidal capsules, and the seeds. The extract dosage for each subject is approximately 150 mls per dose. The extract is administered orally, twice a day with a 10-12 hour interval in between the doses. The average treatment for high risk cases lasts 30-45 days (i.e., full blown AIDS), and for simple cases the treatment lasts for 10-20 days (i.e., HIV positive). All subjects who underwent treatment were under the supervision of their private doctors. Moreover, it was recommended that the subjects undergo daily non-strenuous, light exercises along with a specific low fat diet program.

Prior to the Examples as hereinafter set forth wherein various subjects ingested the extract, the toxicity of the plant extract used in the inventive method was tested in two independent toxicity studies. Each study was directed to examining the behavioral and physiological aspects of laboratory animals which were given the plant extract.

The first study involved using five rabbits as models. Animal rooms and cages were cleansed and sanitized prior to initiating the study and then weekly thereafter. The light/dark cycle in the animal rooms and cages was kept on a 12L:12D schedule while the temperature was maintained at 70-75 degrees Fahrenheit. The normal water supply of the test animals was replaced with the plant extract for a two week period. Thereafter, city quality tap water was again supplied. No irregularities in the animals' behavior subsequent to plant extract consumption were noted. Thus, the non-toxicity of the extract was confirmed. Moreover, two days after returning the animals back to the tap water, a limited gross necropsy was performed on two of the animals to examine any change in the internal organs. No apparent changes were observed in these animals. The rest of the animals were examined again after a two month period and there were still no discernible effects on the animals. The first study lasted approximately two months.

A second toxicity study was carried out with a group of ten mice. This study involved varying the concentration of the extract. The variable concentrations were calculated by ratios between parts of the plant weight in grams and solvent volume. Thus, the mice were administered 1 ml doses of plant extract at concentrations of 25%, 50%, and 100%. Again, no adverse reactions were noted. The test animals appeared normal irrespective of dose, supporting a second conclusion of non-toxicity. All animals were kept in accordance with accepted animal care practice.

DETAILED DESCRIPTION OF THE INVENTION

The present invention contemplates a method for treating HIV positive subjects by administering an effective amount of a therapeutically active composition to a subject. The compositions used resulted in a negative reading for the p24 (HIV) antigen in a group of subjects who initially tested positive for the p24 (HIV) antigen. Also, the composition used in the method maintains a negative reading for the p24 (HIV) antigen in a subject that initially tested negative for the p24 (HIV) antigen.

Therefore, it is concluded that the composition either neutralizes, destroys or, in some manner, inhibits the HIV virus.

My composition is prepared by collecting and washing approximately three or four dry Asphodelus tenuifolius plants. The entire plant is included in the extract, including the whole woody stem, the root system, the loculicidal capsules, and the seeds. Each loculicidal capsule contains from five to six seeds, with the number of seeds on one plant being within the range of 300-500 depending on the plant's growth. About 40 to about 60 grams (which corresponds to three or four plants of Asphodelus tenuifolius are placed into about 1.5 to 2.5 liters, and preferably about 2 liters of water. The water is then boiled for about twenty minutes during which time the extraction process occurs. Approximately 600 milliliters of the water evaporates during boiling. A residue will form during the extraction process. The residue along with the boiled plant(s) are removed by filtering so that the remaining solution contains only the Asphodelus tenuifolius extract mixed in with the water. The plant extract solution is preferably stored in a dark, cool environment having a temperature of from about 4.degree. C. to about 8.degree. C. About 150 to about 170 mls per dose is ingested by each subject. The plant extract is administered orally, twice a day with a 10-12 hour interval in between the doses. In a preferred embodiment about 50 to about 500 mg of a cortisone product is dissolved in about 150 to about 170 ml dose and this is administered to the subjects for at least 5 days. The average treatment lasts for 10-45 days. This varies depending on the subject. All subjects undergoing treatment were under the supervision of their private doctors. Moreover, it was recommended that the subjects undergo daily non-strenuous, light exercises along with a specific low fat diet program.

Nine HIV positive male human subjects were treated by the inventive method. They were between the ages of 30 to 66 years old and were each in the high risk group. However, most of the subjects were asymptomatic. All nine subjects were examined for blood cell counts prior to the plant extract treatment. The subclasses of T-cells (T3, T4, T8) were studied before treatment, sometimes after approximately ten days, and at the end of each treatment. The plant extract was supplied to each subject twice daily in oral dosages of 150-170 ml each.

For each subject, one of the doses on each the first and second day there was dissolved about 125mg (a 1/4 of 500 mg tablet) of the cortisone Medrol which is described as 1-dehydro-6-.alpha.-methylhydrocortisone by the 10th Edition of Merck Index p. 875 (5984). On each of the 3rd and 4th days there was dissolved 250 mg (1/2 tablet) of Medrol in one of the doses. On the fifth day there was dissolved 500 mg (1 tablet) in one of the doses. One each of the sixth and seventh days I dissolved 250 mg in one of the doses. Finally on each of the eighth and ninth days I dissolved 125 mg in one of the doses.

Each of the nine subjects was subjected to the following tests:

(a) p24 antigen test (if more than 40 picograms of the p24 antigen was detected in a subject, then that subject was considered as testing positive);

(b) T-Cell count;

(c) hematological tests (identification of white blood cell types, and blood cell types);

(d) biochemical test;

(e) blood electrolyte variations; and

(f) protein electrophoresis.

The following clinical data (below) was compiled for each of the nine HIV positive subjects treated by the inventive method. The units for measurement, as well as the standard values, are the same for all tests performed for each of the nine subjects.

SUBJECT NO. 1

Subject No. 1 belongs to the high risk HIV positive group. Subject No. 1 was taking AZT and INTERFERON prior to the extract treatment. Subject No. 1 was treated from Oct. 16, 1992 to Nov. 9, 1992. Blood for the Oct. 16, 1992 tests was taken prior to treatment and blood for the Nov. 9, 1992 test was taken after treatment.

Subject No. 1 was tested for the p24 antigen (HIV-AG). Table No. 1 (below) shows the results of the HIV-AG and T-Cell tests. As shown in the table, Subject No. 1 had a positive HIV-AG before treatment with the plant extract and a negative HIV-AG after less than one month of treatment.

                TABLE 1                                                     
     ______________________________________                                    
              OCT                   NOV                                        
              16            OCT     9                                          
     HIV-AG   1992          27      1992                                       
     T CELLS  POSITIVE      1992    NEGATIVE                                   
     ______________________________________                                    
     ANL %     32            34      35                                        
     ANL      1472          1258    1365                                       
     T3%       77            75      81                                        
     T3       1133          943     1105                                       
     T4%        7            4       12                                        
     T4        103           50      163                                       
     T8%       70            70      66                                        
     T8       1030          880      900                                       
     ______________________________________                                    

Table 2 (below) represents specific changes in the white blood cell types of Subject No. 1 before treatment. The first three columns represent test results prior to treatment with the plant extract. The next four columns represent the changes in the number of white blood cells of the subject during the treatment. As shown in table 2, the lymphocytes increased in number most dramatically during days 10-20 of treatment. Likewise, the neutrophils experienced the largest increase during that same time period. The monocytes were remarkably constant with the exception of a decrease on approximately day 17 of treatment.

                TABLE 2                                                     
     ______________________________________                                    
            Oct   Oct    Oct     Oct  Oct   Nov  Nov                           
            14    15     16      21   27    2    9                             
            1992  1992   1992    1992 1992  1992 1992                          
     ______________________________________                                    
     WBC                                                                       
     TYPES                                                                     
     Lymphocytes                                                               
              28      30     32    30   34    35   26                          
     Monocytes                                                                 
              23      20     19    24   18     8   21                          
     Eisinophils                                                               
              --      --     --    --   --    --   --                          
     Basophils                                                                 
              --      --     --    --   --    --   --                          
     Neutrophils                                                               
              49      50     49    46   48    57   53                          
     ______________________________________                                    

Table 3 (below) shows various blood test results taken before, during, and at the end of the treatment with the plant extract. The first three columns represent tests taken before treatment. Columns 4 to 7 represent tests taken after treatment. As the data in table 3 indicates, there is a general increase in each of the different types of blood cells, with the exception of the white blood cells, the MCH, the LYM, and the NEUT cells which remained more or less constant.

                TABLE 3                                                     
     ______________________________________                                    
     Oct        Oct     Oct    Oct   Oct  Nov   Nov                            
     14         15      16     21    27   2     9                              
     1992       1992    1992   1992  1992 1992  1992                           
     ______________________________________                                    
     Blood                                                                     
     Cells                                                                     
     WBC     5.1    4.3     4.6  3.6   3.7  3.9   3.0                          
     RBC     3.13   3.02    3.09 3.16  3.31 3.34  3.4                          
     HNb     11.6   11.3    11.5 11.7  12.1 12.8  12.4                         
     HCT     35.6   34.4    35.3 36.0  37.7 38.2  38.1                         
     MCV     113.7  113.9   114.2                                              
                                 113.9 113.9                                   
                                            114.4 112.1                        
     MCH     37.1   37.4    37.2 37.0  36.6 38.3  36.5                         
     MCHC    32.6   32.8    32.6 32.5  32.1 33.5  32.5                         
     PLT     246    237     234  237   293  287   222                          
     LYM %   28.4   30.0    32.2 30.5  33.9 32.2  26.4                         
     MID %   22.7   19.6    19.0 23.9  17.9 --    21.5                         
     NEUT %  48.9   50.4    48.8 45.6  48.2 --    52.1                         
     LYM     1.4    1.3     1.5  1.1   1.3  1.3   0.8                          
     MID     1.2    0.8     0.9  0.9   0.7  --    0.6                          
     NEUT    2.5    2.2     2.2  1.6   1.7  --    1.6                          
     RDW-CV  11.4   11.5    11.3 11.8  12.0 12.6  12.6                         
     PDW     12.5   12.5    11.6 12.1  12.3 11.8  12.2                         
     MPV     9.9    9.8     9.7  9.6   9.9  9.8   10.1                         
     P-LCR   25.5   24.1    23.1 22.9  25.7 24.7  27.0                         
     ______________________________________                                    

Table 4 (below) discloses the biochemical status of Subject No. 1. The first column represents the status of the subject prior to treatment with the plant extract. Columns 2 and 3 show results of biochemical tests during and at the end of treatment, respectively. Likewise, columns four and five show the measurements units and the normal values, respectively, of the different biochemical tests. As shown in table 4, many of the biochemical tests (i.e., cholesterol, HDL, LDL, phosphorus) showed increases during treatment of Subject No. 1 whereas, most of the biochemical tests (urea, cholesterol, HDL, LDL, triglycerides) showed an overall increase only by the end of the treatment. In contrast, the data for creatinine remained the same by the end of the treatment, while data for phosphorus and magnesium showed a slight decrease. There was no data for the calcium level of Subject No. 1 prior to treatment. However, the calcium level data showed a decrease by the end of the treatment. All of the data was within the range of normal values (shown in the fifth column), with the exception of the HDL, LDL, and triglycerides data.

                TABLE 4                                                     
     ______________________________________                                    
              Oct     Oct     Nov                                              
     Biochemical                                                               
              16      27      9             Normal                             
     Tests    1992    1992    1992  Units   Values                             
     ______________________________________                                    
     Urea     30      30      36    mg/100 ml                                  
                                            15-55                              
     Cholesterol                                                               
              158     181     180   "       125-260                            
     HDL      29      33      31    "       30-65                              
     LDL      96      114     107   "        88-188                            
     Triglycerides                                                             
              189     170     212   "        40-160                            
     Creatinine                                                                
              1.2     1.1     1.2   "       0.9-1.5                            
     Calcium  --      9.5     9.0   "        8.1-10.4                          
     Phosphorus                                                                
              3.1     3.3     3.0   "       2.5-4.5                            
     Magnesium                                                                 
              2.0     2.0     1.9   mEq/1   1.7-2.4                            
     ______________________________________                                    

Table 5 (below) shows changes in blood electrolytes of Subject No. 1. All values are measured in mEq/l. The first column shows the results before treatment with the plant extract. The second and third columns reflect data accumulated during and the end of treatment, respectively. The fourth column shows normal values for blood electrolyte data. As indicated in the table, all of the values were within the normal ranges. There were increases in the potassium, sodium, chloride, gamma-GT, and Alp electrolytes from prior to treatment to the end of treatment. The trans-Go electrolytes decreased while the trans-GP remained the same.

                TABLE 5                                                     
     ______________________________________                                    
                 OCT    OCT        NOV                                         
                 16     27         9    Normal                                 
     Electrolytes                                                              
                 1992   1992       1992 Values                                 
     ______________________________________                                    
     K           4.5    5.7        4.8  3.5-5.1                                
     Na          138    133        141  136-146                                
     Cl          106    102        102   98-107                                
     Trans-Go    30     20         25    5-40                                  
     Trans-GP    20     15         20    5-40                                  
     .gamma.-GT  24     30         35   10-50                                  
     Alp         66     83         67    30-125                                
     ______________________________________                                    

Table 6 (below) shows the results of electrophoresis for Subject No. 1. The first column shows the results before treatment with the plant extract, the second column shows the results during treatment, and the third column shows the results at the end of the treatment. The fourth column shows the normal values. As shown in table 5, most of the protein electrophoresis data (i.e., albumin, a1, gamma) is within the range of normal values by the end of the treatment. The only increases among the data were in the albumin and albumin to globulin ratio.

                TABLE 6                                                     
     ______________________________________                                    
                 OCT    OCT       NOV                                          
     Protein     16     27        9    Normal                                  
     Electrophoresis                                                           
                 1992   1992      1992 Values                                  
     ______________________________________                                    
     ALBUMIN     50.3   54.9      55.5 52-65                                   
     a1          3.3    3.5       3.3    2-4.5                                 
     a2          9.1    9.4       8.7  11-15                                   
     .beta.      16.7   15.3      14.1  6-13                                   
     .gamma.     20.6   16.9      18.4 10-19                                   
     Alb/Glob.sup.1                                                            
                 1.01   1.22      1.25                                         
     ______________________________________                                    
      .sup.1.Ratio between Albumin to Globulin                                 
SUBJECT NO. 2

This HIV positive and asymptomatic subject was taking AZT primarily and later DDI. Subject No. 2 was treated in the same manner as Subject No. 1. Specifically, subject No. 2 was treated from Oct. 16, 1992 to Nov. 11, 1992. Blood for the Oct. 16, 1992 test was taken prior to treatment, while blood for the Nov. 11, 1992 test was taken after treatment. The units for measurement as well as the standard values are the same as with Subject No. 1.

Table 7 (below) shows the results of the HIV-AG and T-cell tests. Subject No. 2 was HIV-AG positive before treatment and HIV-AG negative after less than one month of treatment. As the table indicates, the T-cells generally decreased or remained the same over the time period beginning prior to treatment until after the treatment.

                TABLE 7                                                     
     ______________________________________                                    
              OCT                   NOV                                        
              16            OCT     11                                         
     HIV-AG   1992          20      1992                                       
     T CELLS  POSITIVE      1992    NEGATIVE                                   
     ______________________________________                                    
     ANL %    35            39      28                                         
     ANL      840           858     532                                        
     T3%      77            62      63                                         
     T3       1192          330     335                                        
     T4%       5             3       5                                         
     T4       42            16      26                                         
     T8%      69            50      55                                         
     T8       579           266     292                                        
     ______________________________________                                    

Table 8 (below) represents specific changes in white blood cell types of Subject No. 2. The first three columns show the test results prior to treatment with the plant extract. The next four columns represent the changes in white blood cells types during the treatment. As the data in the table reveals, the lymphocytes decreased while the monocytes and neutrophils increased.

                TABLE 8                                                     
     ______________________________________                                    
            Oct   Oct    Oct     Oct  Oct   Nov  Nov                           
            14    15     16      21   29    5    11                            
            1992  1992   1992    1992 1992  1992 1992                          
     ______________________________________                                    
     WBC TYPES                                                                 
     Lymphocytes                                                               
              48      40     35    29   39    41   28                          
     Monocytes                                                                 
              13      11     10    15   14    18   19                          
     Eosinophils                                                               
              --       1     --    --   --    --   --                          
     Basophils                                                                 
              --      --     --    --   --    --   --                          
     Neutrophils                                                               
              39      48     65    56   47    41   53                          
     ______________________________________                                    

Table 9 (below) shows various blood test results taken before, during, and at the end of the treatment with the plant extract. The first three columns in the table represent tests taken before treatment. Columns four to seven represent tests taken after treatment. Most of the test data (WBC, MCV, MCH, HC, PLT, LYM%, LYM, PDW, MPV, P-LCR) showed an overall decrease over the course of the treatment. However, the data for the white blood cells and the platelets showed an increase during days 10-20 of the treatment but a decrease at the end of the treatment.

                TABLE 9                                                     
     ______________________________________                                    
     Oct        Oct     Oct    Oct   Oct  Nov   Nov                            
     14         15      16     21    29   5     11                             
     1992       1992    1992   1992  1992 1992  1992                           
     ______________________________________                                    
     Blood                                                                     
     Cells                                                                     
     WBC     2.4    2.4     2.4  1.6   2.2  3.0   1.9                          
     RBC     3.47   3.43    3.55 3.23  3.83 3.69  3.71                         
     Hb      11.8   11.7    12.1 10.9  12.3 12.0  11.9                         
     HT      36.5   36.0    37.1 33.4  38.6 36.8  36.9                         
     MCV     105.2  105.0   104.5                                              
                                 103.4 100.8                                   
                                            99.7  99.5                         
     MCH     34.0   34.1    34.1 33.7  32.1 32.5  32.1                         
     HC      32.3   32.5    32.6 32.6  31.9 32.6  32.2                         
     PLT     166    161     162  165   220  206   160                          
     LYM %   48.2   42.3    35.3 28.9  38.7 41.4  28.4                         
     MID %   12.9   --      10.1 14.9  13.8 18.0  26.2                         
     NEUT %  38.9   --      54.6 56.2  47.5 40.6  45.4                         
     LYM     1.2    1.0     0.8  0.5   0.9  1.2   0.5                          
     MID     0.3    --      0.2  0.2   0.3  0.5   0.5                          
     NEUT    0.9    --      1.4  0.9   1.0  1.3   0.9                          
     RDW-    12.1   12.2    11.4 12.1  12.1 12.9  12.8                         
     CV                                                                        
     PDW     15.4   14.7    14.8 12.6  14.7 13.6  13.6                         
     MPV     11.3   11.5    11.4 11.0  11.4 10.9  11.0                         
     P-LCR   37.0   37.9    36.8 33.1  36.5 32.3  32.2                         
     ______________________________________                                    

Table 10 (below) represents the biochemical status of Subject No. 2. The first column represents the status of the subject prior to treatment with the plant extract. Columns 2 and 3 show data for biochemical tests performed during treatment and at the end of treatment. The fourth and fifth columns reflect the measurement units and the normal values for each of the biochemical tests. As the table indicates, there was an overall increase in the cholesterol, triglycerides, and calcium of Subject No. 2 during the course of treatment. With the exception of the biochemical test for HDL, all of the tests showed data that was within the range of normal values by the end of the treatment.

                TABLE 10                                                    
     ______________________________________                                    
              Oct     Oct     Nov                                              
     Biochemical                                                               
              16      29      11            Normal                             
     tests    1992    1992    1992  Units   Values                             
     ______________________________________                                    
     Urea     29      36      27    mg/100 ml                                  
                                            15-55                              
     Cholesterol                                                               
              171     142     172   "       125-260                            
     HDL      29      23      29    "       30-65                              
     LDL      130     91      130   "        88-188                            
     Triglycerides                                                             
              61      105     68    "        40-160                            
     Creatinine                                                                
              1.2     1.1     1.0   "       0.9-1.5                            
     Calcium  3.1     9.1     8.9   "        8.1-10.4                          
     Phosphorus                                                                
              3.2     3.9     3.2   "       2.5-4.5                            
     Magnesium                                                                 
              2.0     2.1     2.0   mEq/1   1.7-2.4                            
     ______________________________________                                    

Table 11 (below) shows changes in the blood electrolytes of Subject No. 2. All values were measured in mEq/. The first column represents the results before treatment with the plant extract. The second and third columns represent during treatment and the end of treatment, respectively. The fourth column reflects the range of normal values for each of the above tests. As shown in table 11, the various blood electrolytes increased over the course of the treatment, except for the potassium and chloride electrolytes. All of the tests show data within the range of normal values for each of the tests by the end of the treatment.

                TABLE 11                                                    
     ______________________________________                                    
                 Oct    Oct        Nov                                         
                 16     29         11   Normal                                 
     Electrolytes                                                              
                 1992   1992       1992 Values                                 
     ______________________________________                                    
     K           4.4    4.2        4.2  3.5-5.1                                
     Na          135    137        144  136-146                                
     Cl          107    102        98    98-107                                
     Trans-Go    28     30         30    5-40                                  
     Trans-GP    18     21         38    5-40                                  
     .gamma.-GT  15     20         40   10-50                                  
     Alp         48     62         66    30-125                                
     ______________________________________                                    

Table 12 (below) discloses the results from the protein electrophoresis of Subject No. 2. The first column reflects the data before treatment with the plant extract. The second column shows data during treatment. The third column shows data at the end of treatment. The fourth column indicates the range of normal values. As shown in table 12, increases in data occurred only in Alb and Alb/Glob ratio, with the highest increases being during days 10-20 of the treatment. The data in table 12 also reflects that the protein electrophoresis was within the range of normal values, with the exception of the Alb (which was within the range of normal values only during the middle of the treatment), a2, and gamma.

                TABLE 12                                                    
     ______________________________________                                    
                 Oct    Oct       Nov                                          
     Protein     16     29        11   Normal                                  
     Electrophoresis                                                           
                 1992   1992      1992 Values                                  
     ______________________________________                                    
     Alb         46.4   53.1      49.4 52-65                                   
     a1          2.9    2.2       2.8    2-4.5                                 
     a2          7.5    6.4       7.6  11-15                                   
     .beta.      12.9   10.1      12.7  6-13                                   
     .gamma.     30.3   28.2      27.5 10-19                                   
     Alb/Glob    0.87   1.13      0.98                                         
     ______________________________________                                    
SUBJECT NO. 3

Subject No. 3 was suffering from a number of allergies. Subject No. 3 was not on any type of medication other than Ginseng and other herbal serums. Subject No. 3 was treated from Oct. 16, 1992 to Nov. 16, 1992. Blood for the Oct. 16, 1992 test was taken prior to treatment and blood for the Nov. 16, 1992 test was taken after treatment. The same type of testing was performed on Subject No. 3 as with the previous subjects. The units for measurement, as well as the standard values, are the same for Subject No. 3 as with the prior subjects.

Table 13 (below) shows another positive result. Subject No. 3 was initially tested for the p24 antigen (HIV-AG) and revealed a positive HIV-AG before treatment with the plant extract and a negative HIV-AG after less than one month of treatment. As shown in table 13, the T3 and T4 cells increased, while the T8 cells remained the same.

                TABLE 13                                                    
     ______________________________________                                    
              OCT                   NOV                                        
              16            NOV     16                                         
     HIV-AG   1992          9       1992                                       
     T CELLS  POSITIVE      1992    NEGATIVE                                   
     ______________________________________                                    
     ANL %     50            30      29                                        
     ANL      2300          2250    2581                                       
     T3%       87            85      81                                        
     T3       2001          1912    2090                                       
     T4%       19            16      18                                        
     T4        437           360     464                                       
     T8%       60            62      60                                        
     T8       1380          1385    1548                                       
     ______________________________________                                    

Table 14 (below) represents specific changes in the white blood cell types of Subject No. 3 before treatment with the plant extract. The first three columns show the test results before treatment. The last three columns represent the changes of white blood types during treatment. As shown in table 14, the lymphocytes, monocytes, and eosinophils decreased, while the increased in number.

                TABLE 14                                                    
     ______________________________________                                    
              Oct     Oct     Oct   Oct   Nov   Nov                            
              14      15      16    29    9     16                             
     WBC TYPES                                                                 
              1992    1992    1992  1992  1992  1992                           
     ______________________________________                                    
     Lymphocytes                                                               
              44      46      50    50    30    29                             
     Monocytes                                                                 
              21      14      17     9     7     6                             
     Eosinophils                                                               
              --       4      --    --     3     3                             
     Basophils                                                                 
              --      --      --    --    --    --                             
     Neutrophils                                                               
              35      36      33    41    60    62                             
     ______________________________________                                    

Table 15 (below) shows various blood test results taken before, during, and at the end of treatment with the plant extract. The first three columns represent tests taken before treatment. Columns four to six represent tests taken after treatment. As shown in table 15, the data for the white blood cells reflects an increase by almost half. Increases were also shown in the red blood cells, the hemoglobin, HCT, MCV, MCH, PLT, LYM%, NEUT%, LYM, NEUT, and PDW. Most of the increases were reflected in days 10-20 of the treatment. The MID% decreased, whereas the MCHC, MID, RDW-CV, MP, and P-LCR remained approximately the same.

                TABLE 15                                                    
     ______________________________________                                    
            Oct  Oct      Oct    Oct    Nov  Nov                               
            14   15       16     29     9    16                                
            1992 1992     1992   1992   1992 1992                              
     ______________________________________                                    
     Blood                                                                     
     Cells                                                                     
     WBC      4.7    4.7      4.6  7.1    7.5  8.9                             
     RBC      4.64   4.54     4.69 5.02   4.64 4.48                            
     Hb       13.5   13.5     13.9 15.0   13.9 13.2                            
     HCT      41.3   40.5     42.3 45.0   42.2 40.3                            
     MCV      89.0   89.2     90.2 89.6   90.9 90.0                            
     MCH      29.1   29.7     29.6 29.9   30.0 29.5                            
     MCHC     32.7   33.3     32.9 33.3   32.9 32.8                            
     PLT      324    322      299  290    344  439                             
     LYM %    44.1   44.8     50.1 49.6   30.6 29.5                            
     MID %    21.2   19.7     16.8 8.7    12.2 10.2                            
     NEUT %   34.7   35.5     33.1 41.7   57.2 60.3                            
     LYM      2.1    2.1      2.3  3,5    2.3  2.6                             
     MID      1.0    0.9      0.8  0.6    0.9  0.9                             
     NEUT     1.6    1.7      1.5  3.0    4.3  5.4                             
     RDW-CV   12.9   13.5     12.6 13.1   13.1 12.7                            
     PDW      14.7   14.0     13.0 14.1   15.0 14.9                            
     MP       11.3   10.6     10.5 10.8   11.2 11.1                            
     P-LCR    36.3   31.2     30.1 31.7   35.2 35.0                            
     ______________________________________                                    

Table 16 (below) describes the biochemical status of Subject No. 3. The first column represents the status of the subject prior to treatment with the plant extract. Columns 2 and 3 show data from biochemical tests during treatment and at the end of treatment, respectively. The fourth and fifth columns list the measurement units and the normal values, respectively. All of the data for the biochemical tests was within the range of normal values. In addition, all of the data reflects increases, except for the HDL and phosphorus.

                TABLE 16                                                    
     ______________________________________                                    
              Oct     Nov     Nov                                              
     Biochemical                                                               
              16      9       16            Normal                             
     Tests    1992    1992    1992  Units   Values                             
     ______________________________________                                    
     Urea     30      25      38    mg/100 ml                                  
                                            15-55                              
     Cholesterol                                                               
              141     174     191   "       125-260                            
     HDL      42      36      34    "       30-65                              
     LDL      92      116     132   "        88-188                            
     Triglycerides                                                             
              86      112     111   "        40-160                            
     Creatinine                                                                
              1.0     1.2     1.3   "       0.9-1.5                            
     Calcium  8.7     8.7     9.4   "        8.1-10.4                          
     Phosphorus                                                                
              3.5     3.1     3.2   "       2.5-4.5                            
     Magnesium                                                                 
              1.8     1.9     2.0   mEq/1   1.7-2.4                            
     ______________________________________                                    

Table 17 (below) shows changes in the blood electrolytes of Subject No. 3. All values were measured in mEq/l. The first column reflects the results before treatment with the plant extract. The second and third columns represent during and the end of treatment, respectively. The fourth column shows the range of normal values. All of the data showed values within the range of normal values. The potassium and sodium electrolytes showed an increase during the treatment but a decrease at the end of the treatment. All the remaining electrolytes reflected a decrease as a result of the treatment.

                TABLE 17                                                    
     ______________________________________                                    
                 Oct    Nov        Nov                                         
                 16     9          16   Normal                                 
     Electrolytes                                                              
                 1992   1992       1992 Values                                 
     ______________________________________                                    
     K           4.3    4.6        4.1  3.5-5.1                                
     Na          136    137        142  136-146                                
     Cl          105    99         102   98-107                                
     Trans-GO    32     17         17    5-40                                  
     Transam-GP  42     12         12    5-40                                  
     .gamma.-GT  48     13         22   10-50                                  
     Alp         64     57         59    30-125                                
     ______________________________________                                    

Table 18 (below) demonstrates the results of electrophoresis. The first column shows the results prior to treatment with the plant extract. The second column shows the results during the treatment, and the third column reflects the results at the end of the treatment. The fourth column shows the range of normal values. All the data was within the range of normal values and showed an increase, except for the gamma and albumin/globulin ratio.

                TABLE 18                                                    
     ______________________________________                                    
                 OCT    NOV       NOV                                          
     Protein     16     9         16   Normal                                  
     Electrophoresis                                                           
                 1992   1992      1992 Values                                  
     ______________________________________                                    
     Alb         45     46.3      45.4 52-65                                   
     a1          2.5    3.1       3.2    2-4.5                                 
     a2          9.9    12.3      12.5 11-15                                   
     .beta.      10.7   9.6       10.8  6-13                                   
     .gamma.     31.9   28.7      28.1 10-19                                   
     Alb/Glob    0.82   0.86      0.83                                         
     ______________________________________                                    
SUBJECT NO. 4

Subject No. 4, along with subjects 5 through 9, was diagnosed HIV positive but tested negative for the HIV antigen at both the beginning and end of the treatment. Subject No. 4 was apparently not taking any drugs, including AZT. Subject No. 4 was treated from Oct. 15, 1992 to Nov. 9, 1992. Blood for the Oct. 15, 1992 tests was taken prior to treatment and blood for the Nov. 9, 1992 test was taken after treatment.

Table 19 (below) reveals that Subject No. 4 tested negative for HIV-AG before and after the treatment with the plant extract. The T-3 and T-8 cells increased significantly as a result of the treatment.

                TABLE 19                                                    
     ______________________________________                                    
              OCT                   NOV                                        
              12            OCT     9                                          
     HIV-AG   1992          27      1992                                       
     T CELLS  NEGATIVE      1992    NEGATIVE                                   
     ______________________________________                                    
     ANL %    25             21      23                                        
     ANL      600           525     563                                        
     T3       200           378     309                                        
     T3%      80             72      55                                        
     T4       42.5           21      23                                        
     T4%      17             4       4                                         
     T8       152           346     261                                        
     T8%      61             66      44                                        
     ______________________________________                                    

Table 20 (below) discloses specific changes in white blood cell types of Subject No. 4 before treatment with the plant extract. The first 3 columns show the test results prior to treatment. The next four columns represent the changes in the white blood cells during the treatment. As shown in table 20, the monocytes significantly increased by the end of treatment. The neutrophils increased during the middle of the treatment but remained approximately 8 then decreased by the end of the treatment. The lymphocytes remained approximately the same.

                TABLE 20                                                    
     ______________________________________                                    
            Oct   Oct    Oct     Oct  Oct   Nov  Nov                           
            12    14     15      21   27    2    9                             
            1992  1992   1992    1992 1992  1992 1992                          
     ______________________________________                                    
     WBC                                                                       
     TYPES                                                                     
     Lymphocytes                                                               
              10      23     25    22   21    23   18                          
     Monocytes                                                                 
              13       3     10    12    4     9   58                          
     Eosinophils                                                               
              20      --      2    --   --    --   --                          
     Basophils                                                                 
              --      --     --    --   --    --   --                          
     Neutrophils                                                               
              57      74     63    66   75    68   24                          
     ______________________________________                                    

Table 21 (below) shows various blood test results taken before, during, and at the end of the treatment with the plant extract. The first three columns represent tests taken before treatment with the plant extract. Columns four to seven represent tests taken after treatment, and the last two columns represent the range of normal values and the unit measurement. Most of the data showed an increase. The MCHC, PLT, and LYN% increased during the treatment but decreased or remained the same by the end of the treatment. The MCV, MCH, NEUT%, and NEUT data showed a decrease.

                                    TABLE 21                                
     __________________________________________________________________________
     Oct      Oct Oct Oct Oct                                                  
                             Nov Nov                                           
     12       14  15  21  27 2   9                                             
     1992     1992                                                             
                  1992                                                         
                      1992                                                     
                          1992                                                 
                             1992                                              
                                 1992                                          
     __________________________________________________________________________
     Blood                          Normal                                     
                                         Units                                 
     Cells                                                                     
     WBC   2.5                                                                 
              2.5 2.4 2.6 2.5                                                  
                             3.6 3.3                                           
                                    4.8- K/ul                                  
                                    10.8                                       
     RBC   3.8                                                                 
              3.98                                                             
                  3.93                                                         
                      3.87                                                     
                          3.95                                                 
                             4.22                                              
                                 4.12                                          
                                    4.4- M/ul                                  
                                    5.8                                        
     HNb   8.7                                                                 
              8.9 9.0 8.9 8.9                                                  
                             9.4 8.9                                           
                                    13.9-                                      
                                         g/dl                                  
                                    17.5                                       
     HCT   28.1                                                                
              29.2                                                             
                  28.7                                                         
                      27.8                                                     
                          28.2                                                 
                             30.1                                              
                                 28.7                                          
                                    42.0-                                      
                                         %                                     
                                    52.5                                       
     MCV   73.9                                                                
              73.4                                                             
                  73.0                                                         
                      71.8                                                     
                          71.4                                                 
                             71.3                                              
                                 69.7                                          
                                    80.5-                                      
                                         fl                                    
                                    98.5                                       
     MCH   22.9                                                                
              22.4                                                             
                  22.9                                                         
                      23.0                                                     
                          22.5                                                 
                             22.3                                              
                                 21.6                                          
                                    25.5-                                      
                                         pg                                    
                                    34.5                                       
     MCHC  31.0                                                                
              30.5                                                             
                  31.4                                                         
                      32.0                                                     
                          31.6                                                 
                             31.2                                              
                                 31.0                                          
                                    31.5--                                     
                                         pg                                    
                                    36.5                                       
     PLT   464.0                                                               
              481 207 480 215                                                  
                             492 192                                           
                                    150- K/ul                                  
                                    350                                        
     LYM % 20.6                                                                
              23.5                                                             
                  23.0                                                         
                      22.1                                                     
                          23.0                                                 
                             21.0                                              
                                 18.0                                          
                                    20-45                                      
                                         %                                     
     MID % 52.2                                                                
              2.8 --  --  -- --  58.3                                          
                                    1-15 %                                     
     NEUT %                                                                    
           27.2                                                                
              73.7                                                             
                  --  --  -- --  23.7                                          
                                    45-80                                      
                                         %                                     
     LYM   0.5                                                                 
              0.6 0.6 0.6 0.6                                                  
                             0.8 0.6                                           
                                    1.0- K/ul                                  
                                         4.0                                   
     MID   1.3                                                                 
              0.1 --  --  -- --  1.9                                           
                                    0-1  K/ul                                  
     NEUT  0.7                                                                 
              1.8 --  --  -- --  0.8                                           
                                    2.6- K/ul                                  
                                         9.0                                   
     RDW-CV                                                                    
           15.1                                                                
              15.6                                                             
                  16.0                                                         
                      15.8                                                     
                          16.2                                                 
                             16.0                                              
                                 15.3                                          
                                    11.0-                                      
                                         %                                     
                                         16.0                                  
     PDW   -- --  --  --  -- --  -- 9.0- $                                     
                                         17.0                                  
     MPV   -- --  --  --  -- --  -- 9.0- fl                                    
                                         13.0                                  
     P-LCR -- --  --  --  -- --  -- 13-43                                      
                                         %                                     
     __________________________________________________________________________

Table 22 (below) describes the biochemical status of Subject No. 4. The first column represents the status of the subject prior to treatment with the plant extract. Columns 2 and 3 show data for biochemical tests taken during treatment and at the end of treatment, respectively. The fourth and fifth columns list the measurement units and the range of normal values, respectively. The data from the tests showed that the cholesterol and triglycerides increased, with the highest value of the triglycerides being in the middle of the treatment. All other biochemical tests were within the range of normal values, except for the HDL and triglycerides.

                TABLE 22                                                    
     ______________________________________                                    
              Oct     Oct     Nov                                              
     Biochemical                                                               
              12      27      9             Normal                             
     Tests    1992    1992    1992  Units   Values                             
     ______________________________________                                    
     Urea     36      34      36    mg/100 ml                                  
                                            15-55                              
     Cholesterol                                                               
              87      100     102   "       125-260                            
     HDL      29      34      29    "       30-65                              
     LDL      52      62      51    "        88-188                            
     Triglycerides                                                             
              152     312     212   "        40-160                            
     Creatinine                                                                
              1.2     1.0     1.2   "       0.9-1.5                            
     Calcium  --      9.8     8.8   "        8.1-10.4                          
     Phosphorus                                                                
              --      3.4     2.9   "       2.5-4.5                            
     Magnesium                                                                 
              --      1.9     1.8   mEq/1   1.7-2.4                            
     ______________________________________                                    

Table 23 (below) shows changes in the blood electrolytes of Subject No. 4. All values were measured in mEq/l. The first column reflects the results before treatment with the plant extract. The second and third columns represent during and the end of the treatment, respectively. The fourth column shoes the range of normal values. As shown in table 23, all data was within the range of normal values by the end of the treatment. Also, there was an increase in the sodium, gamma-GT, and Alp electrolytes.

                TABLE 23                                                    
     ______________________________________                                    
                OCT    OCT       NOV                                           
                12     27        9                                             
     Electrolytes                                                              
                1992   1992      1992 Normal Values                            
     ______________________________________                                    
     K          --     5.2       5.0  3.5-5.1                                  
     Na         --     134       140  136-146                                  
     Cl         --     103       102  98-107                                   
     Trans-Go   35     29        23   5-40                                     
     Trans-GP   18     17        18   5-40                                     
     .gamma.-GT 12     16        22   10-50                                    
     Alp        63     89        84   30-125                                   
     ______________________________________                                    

Table 24 (below) reflects the results of protein electrophoresis. The first column shows the results prior to treatment with the plant extract. The second column reflects the results during treatment. The third column shows the results at the end of the treatment. The fourth column shows the range of normal values. As indicated by the table, all the values were outside of the normal range by the end of the treatment, except for the a1 data. Moreover, the only increases in data were in the a2 and gamma data.

                TABLE 24                                                    
     ______________________________________                                    
                  OCT    OCT       NOV                                         
     Protein      12     27        9    Normal                                 
     Electrophoresis                                                           
                  1992   1992      1992 Values                                 
     ______________________________________                                    
     ALBUMIN      45.4   43.9      42.3 52-65                                  
     a1           3.5    3.3       3.3    2-4.5                                
     a2           9.4    10.1      10.7 11-15                                  
     .beta.       14.4   12.1      13.1  6-13                                  
     .gamma.      24.3   30.6      30.6 10-19                                  
     Alb/Glob.sup.2                                                            
                  0.83   0.78      0.73                                        
     ______________________________________                                    
      .sup.2 Ratio between Albumin to Globulin                                 
SUBJECT NO. 5

Subject No. 5 was also from the HIV positive asymptomatic group and was taking AZT before treatment with the plant extract. Subject No. 5 was treated from Oct. 21, 1992 to Nov. 9, 1992. Blood for the Oct. 21, 1992 tests was taken prior to treatment and blood for the Nov. 9, 1992 test was taken after treatment. The same tests were performed on Subject No. 5 as were performed on the previous subjects. Moreover, the units for measurement, as well as the standard values, are the same as those used for the preceding subjects.

Table 25 (below) shows the results of the HIV-AG and T-cell tests. Subject No. 5 had a negative HIV-AG before and after treatment, and a negative HIV-AG after less than one month of treatment. The T-3 and T-8 cells increased significantly over the course of the treatment.

                TABLE 25                                                    
     ______________________________________                                    
                   Oct       Nov                                               
                   21        9                                                 
     HIV           1992      1992                                              
     T CELLS       NEGATIVE  NEGATIVE                                          
     ______________________________________                                    
     ANL %         32        43                                                
     ANL           1312      1548                                              
     T3%           82        93                                                
     T3            1075      1439                                              
     T4%           7.5       8                                                 
     T4            98        123                                               
     T8%           72        84                                                
     T8            944       1300                                              
     ______________________________________                                    

Table 26 (below) represents changes in the white blood cell types of Subject No. 5 before treatment with the plant extract. The first two columns show the test results before treatment. The next two columns represent the changes of white blood cells during the treatment. As shown in the table, the lymphocytes and monocytes increased as a result of the treatment, whereas the neutrophils decreased.

                TABLE 26                                                    
     ______________________________________                                    
                  Oct    Oct        Nov  Nov                                   
     WBC          19     21         5    9                                     
     TYPES        1992   1992       1992 1992                                  
     ______________________________________                                    
     Lymphocytes  28     32         40   43                                    
     Monocytes     1      9         11   12                                    
     Eosinophills --     --         --   --                                    
     Basophills   --     --         --   --                                    
     Neutrophils  71     59         49   45                                    
     ______________________________________                                    

Table 27 (below) shows various blood test results taken before, during, and at the end of the treatment with the plant extract. The first two columns represent tests taken before treatment. Columns three and four represent tests taken after treatment. As indicated in table 27, there was an overall increase in most types of blood cells with only a few exceptions. The white blood cells, PLT, NEUT%, NEUT, and RDW-CV decreased, while the MCHC and MID remained approximately the same.

                TABLE 27                                                    
     ______________________________________                                    
                 Oct    Oct        Nov  Nov                                    
     Blood       9      21         5    9                                      
     Cells       1992   1992       1992 1992                                   
     ______________________________________                                    
     WBC         6.0    4.1        4.7  3.6                                    
     RBC         2.98   3.01       3.35 3.47                                   
     Hb          11.4   11.5       13.0 13.3                                   
     HCT         33.9   34.3       38.2 39.6                                   
     MCV         113.8  114.0      114.0                                       
                                        114.0                                  
     MCH         38.3   38.2       38.8 38.3                                   
     MCHC        33.6   33.5       34.0 33.6                                   
     PLT         245    221        220  219                                    
     LYM %       28.5   31.9       37.9 43.0                                   
     MID %       2.3    9.2        --   12.3                                   
     NEUT %      69.2   58.9       --   44.7                                   
     LYM         1.7    1.3        1.8  1.5                                    
     MID         0.1    0.4        --   0.4                                    
     NEUT        4.2    2.4        --   1.7                                    
     RDW-CV      12.5   12.5       11.3 12.4                                   
     PDW         13.3   11.9       13.2 14.5                                   
     MPV         10.4   10.3       10.4 10.8                                   
     P-LCR       28.8   26.7       28.9 31.3                                   
     ______________________________________                                    

Table 28 (below) describes the biochemical status of Subject No. 5. The first column represents the status of the subject prior to treatment with the plant extract. The second column reflects the data from the biochemical tests at the end of the treatment. The third and fourth columns show the range of normal values and the measurement units, respectively. As indicated by the table, the data is generally within the range of normal values and reflects increases only in the tests for urea, HDL, and magnesium.

                TABLE 28                                                    
     ______________________________________                                    
               Oct      Nov                                                    
     Biochemical                                                               
               21       9      Normal                                          
     Tests     1992     1992   Values   Units                                  
     ______________________________________                                    
     Urea      24       26     15-55    mg/1000 ml                             
     Cholesterol                                                               
               192      160    125-260  "                                      
     HDL       31       33     30-65    "                                      
     LDL       129      98      88-188  "                                      
     Triglycerides                                                             
               161      149     40-160  "                                      
     Creatinine                                                                
               1.0      1.0    0.9-1.5  "                                      
     Calcium   9.5      9.2     8.1-10.4                                       
                                        "                                      
     Phosphorus                                                                
               3.6      3.6    2.5-4.5  "                                      
     Magnesium 1.9      2.1    1.7-2.4  mEq/1                                  
     ______________________________________                                    

Table 29 (below) shows changes in the blood electrolytes of Subject No. 5. All values are measured in mEq/l. The first column reflects the results prior to treatment with the plant extract. The second column represents the end of the treatment. The third column shows the range of normal values. All the data is within the range of normal values. Moreover, the data reflects an increase in potassium, sodium, trans-GP, and alp electrolytes.

                TABLE 29                                                    
     ______________________________________                                    
                Oct         Nov                                                
                21          9      Normal                                      
     Electrolytes                                                              
                1992        1992   Values                                      
     ______________________________________                                    
     K          4.1         4.9    3.5-51                                      
     Na         131         142    136-146                                     
     Cl         105         103    98-107                                      
     Trans-GO   27          23     5-40                                        
     Trans-GP   31          32     5-40                                        
     .gamma.-GT 31          30     10-50                                       
     Alp        77          90     30-125                                      
     ______________________________________                                    

Table 30 (below) demonstrates the results of protein electrophoresis. The first column shows the results prior to treatment with the plant extract. The second column reflects the results at the end of treatment. The third column shows the range of normal values. All of the data was within the range of normal values. There was an increase in the data for the beta, gamma, and albumin/globulin ratio.

                TABLE 30                                                    
     ______________________________________                                    
                 Oct        Nov                                                
     Protein     21         9       Normal                                     
     Electrophoresis                                                           
                 1992       1992    Values                                     
     ______________________________________                                    
     Alb         59.7       59.3    52-65                                      
     a1          3.0        3.0       2-4.5                                    
     a2          11.3       11.0    11-15                                      
     .beta.      10.3       10.9     6-13                                      
     .gamma.     15.7       15.8    10-19                                      
     Alb/Glob    1.48       1.46                                               
     ______________________________________                                    
SUBJECT NO. 6

Subject No. 6 belonged to the HIV positive and asymptomatic group. Subject No. 6 was taking AZT up until a few days prior to treatment with the plant extract. Subject No. 6 was treated from Oct. 19, 1992 to Nov. 18, 1992. Blood for the Oct. 19, 1992 test was taken prior to treatment and blood for the Nov. 18, 1992 test was taken after treatment. The same tests were performed on Subject No. 6 as were performed on the previous subjects. The units for measurement, as well as the standard values, are the same as with the previous subjects.

Table 31 (below) shows the results of the HIV-AG and T-cell tests. Subject No. 6 showed a negative HIV-AG before and after treatment. The T-cells showed no significant change.

                TABLE 31                                                    
     ______________________________________                                    
               Oct                  Nov                                        
               19            Oct    18                                         
     HIV-AG    1992          29     1992                                       
     T-CELLS   NEGATIVE      1992   NEGATIVE                                   
     ______________________________________                                    
     ANL %     24            26     27                                         
     ANL       1656          --     --                                         
     T3%       72            71     72                                         
     T3        1192          --     --                                         
     T4%        4             4      3                                         
     T4        66            --     --                                         
     T8%       67            66     65                                         
     T8        1109          --     --                                         
     ______________________________________                                    

Table 32 (below) represents specific changes in the white blood cell types of Subject No. 6 before treatment with the plant extract. The first three columns show the test results prior to treatment. The next four columns represent the changes in white blood cells during the treatment. As shown in the table, the overall number of lymphocytes decreased, while the monocytes increased and the neutrophils remained approximately the same.

                TABLE 32                                                    
     ______________________________________                                    
            Oct   Oct    Oct     Oct  Oct   Nov  Nov                           
            15    16     19      24   29    4    18                            
            1992  1992   1992    1992 1992  1992 1992                          
     ______________________________________                                    
     WBC Types                                                                 
     Lymphocytes                                                               
              26      28     24    19   26    23   14                          
     Monocytes                                                                 
               1       4      1     2    4     1   13                          
     Eosinophils                                                               
              --       2     --    --    2    --   --                          
     Basophils                                                                 
              --      --     --    --   --    --   --                          
     Neutrophils                                                               
              73      66     75    79   68    76   73                          
     ______________________________________                                    

Table 33 (below) shows various blood test results taken before, during, and at the end of the treatment with the plant extract. The first three columns represent tests taken before treatment. Columns four to seven represent tests taken after treatment. As shown in the table, almost all of the blood cell types reflected increases during days 10-20 of the treatment. This increase occurred despite a general decrease in the data by the end of the treatment in many of the blood cells.

                TABLE 33                                                    
     ______________________________________                                    
     Oct        Oct     Oct    Oct   Oct  Nov   Nov                            
     15         16      19     24    29   4     18                             
     1992       1992    1992   1992  1992 1992  1992                           
     ______________________________________                                    
     Blood                                                                     
     Cells                                                                     
     WBC     8.2    7.0     6.9  7.6   8.4  8.6   6.7                          
     RBC     3.98   3.91    3.88 3.76  4.13 4.35  3.90                         
     Hb      12.9   12.6    12.7 12.0  13.4 14.3  12.6                         
     HCT     38.8   38.3    37.8 36.9  40.8 42.5  37.7                         
     CV      97.5   98.0    97.4 98.1  98.8 97.7  96.7                         
     MCH     32.4   32.2    32.7 31.9  32.4 32.9  32.3                         
     MCHC    33.2   32.9    33.6 32.5  32.8 33.6  33.4                         
     PLT     159    153     133  110   186  146   178                          
     LYM %   26.3   28.7    24.5 18.9  26.7 23.5  14.0                         
     MID %   2.7    7.2     2.9  2.4   7.5  2.7   13.1                         
     NEUT %  71.0   64.1    72.6 78.7  65.8 73.8  72.9                         
     LYM     2.2    2.0     1.7  1.4   2.2  2.0   0.9                          
     MID     0.2    0.5     0.2  0.2   0.6  0.2   0.9                          
     NEUT    5.8    4.5     5.0  6.0   5.6  6.4   4.9                          
     RDW-CV  12.5   12.1    12.8 12.4  13.0 13.5  13.3                         
     PDW     13.0   12.9    13.8 14.3  13.0 14.5  11.4                         
     MPV     10.4   10.5    10.4 11.5  10.1 11.0  9.8                          
     P-LCR   29.3   28.5    28.7 38.4  26.6 33.1  23.7                         
     ______________________________________                                    

Table 34 (below) describes the biochemical status of Subject No. 6. The first column represents the status of the subject prior to treatment with the plant extract. Columns two and three reflect data from biochemical tests during and at the end of treatment, respectively. The fourth and fifth columns show the measurement units and the range of normal values for each biochemical test, respectively. As the table shows, the data for the urea and cholesterol tests increased and was especially high during the middle of the treatment. Likewise, the data for the LDL, creatinine, and calcium tests was particularly high during the middle of the treatment. The data for the HDL, triglycerides, calcium, and phosphorus showed a decrease by the end of the treatment.

                TABLE 34                                                    
     ______________________________________                                    
              Oct     Oct     Nov                                              
     Biochemical                                                               
              19      29      18           Normal                              
     Tests    1992    1992    1992  Units  Values                              
     ______________________________________                                    
     Urea     23      49      28    mg/100 ml                                  
                                           15-55                               
     Cholesterol                                                               
              208     328     216   "      125-260                             
     HDL      29      28      25    "      30-65                               
     LDL      131     228     131   "       88-188                             
     Triglycerides                                                             
              341     331     301   "       40-160                             
     Creatinine                                                                
              0.9     1.4     0.9   "      0.9-1.5                             
     Calcium  8.8     9.2     8.4   "       8.1-10.4                           
     Phosphorus                                                                
              4.2     3.8     3.6   "      2.5-4.5                             
     Magnesium                                                                 
              2.0     2.0     2.0   mEq/1  1.7-2.4                             
     ______________________________________                                    

Table 35 (below) shows changes in the blood electrolytes of Subject No. 6. All values were measured in mEq/l. The first column shows the results prior to treatment with the plant extract. The second and third columns represent during and the end of treatment, respectively. The fourth column shows the range of normal values. As the table shows, all of the data is within the range of normal values, except for the alp data which is only within the range during the middle of treatment. Furthermore, there was an increase in the data during the middle of treatment for the potassium electrolytes, and both during and at the end of treatment asa shown by the trans-GP, gamma-GT, and alp data.

                TABLE 35                                                    
     ______________________________________                                    
             Oct  Oct        Nov                                               
             10   29         18                                                
             1992 1992       1992   Normal                                     
     ______________________________________                                    
     K         4.4    4.2        4.5  3.5-5.1                                  
     Na        137    134        133  136-146                                  
     Cl        104    98         101    98-10.7                                
     Trans-GO  28.2   28.0       28.1  5-40                                    
     Trans-GP  16.1   27.0       20.5  5-40                                    
     .gamma.-GT                                                                
               15.48  23         12.71                                         
                                      10-50                                    
     Alp       28.0   32         29.7  30-125                                  
     ______________________________________                                    

Table 36 (below) represents the results of protein electrophoresis. Column 1 shows the results before treatment. Column two shows the results during the treatment, and column three shows the results at the end of the treatment. The fourth column shows the range of normal values. As the table indicates, only the a1 and a2 data is within the range of normal values. Moreover, the table shows that there was an overall increase in the a1, a2, beta, and gamma data.

                TABLE 36                                                    
     ______________________________________                                    
                  Oct    Oct       Nov                                         
     Protein      19     29        18   Normal                                 
     Electrophoresis                                                           
                  1992   1992      1992 Values                                 
     ______________________________________                                    
     Alb          43.2   42.3      39.4 52-65                                  
     a1           2.8    3.0       3.3    2-4.5                                
     a2           10.2   11.5      11.2 11-15                                  
     .beta.       13.2   13.0      14.4  6-13                                  
     .gamma.      30.6   30.2      31.7 10-19                                  
     Alb/Glob     0.76   0.73      0.65                                        
     ______________________________________                                    
SUBJECT NO. 7

Subject No. 7 was taking AZT prior to treatment with the plant extract. Subject No. 7 was treated from Oct. 15, 1992 to Nov. 9, 1992. Blood for the Oct. 15, 1992 tests was taken prior to treatment, and blood for the Nov. 9, 1992 test was taken after treatment. The same tests were performed on Subject No. 7 as with the previous subjects. Likewise, the units for measurement, as well as the standard values, are the same for Subject No. 7 as with the previous subjects.

Table 37 (below) shows the results of the HIV-AG and T-Cell tests. Subject No. 7 tested negative for HIV-AG before and after treatment. As the table indicates, the number of T-cells decreased by the end of the treatment.

                TABLE 37                                                    
     ______________________________________                                    
               Oct                  Nov                                        
               15            Oct    9                                          
     HIV-AG    1992          29     1992                                       
     T-CELLS   NEGATIVE      1992   NEGATIVE                                   
     ______________________________________                                    
     ANL %     19            19     17                                         
     ANL       627           --     --                                         
     T3%       69            71     62                                         
     T3        432           --     379                                        
     T4%        8             5      4                                         
     T4        50            --     24                                         
     T8%       58            62     50                                         
     T8        363           --     306                                        
     ______________________________________                                    

Table 38 (below) represents specific changes in the white blood cell types of Subject No. 7 before treatment with the plant extract. The first three columns are the test results before treatment. The next three columns represent the changes in white blood cells during the treatment. As shown in table 38, there was an overall decrease in the lymphocytes and monocytes. In contrast, there was an increase in the neutrophils.

                TABLE 38                                                    
     ______________________________________                                    
              Oct     Oct     Oct   Oct   Oct   Nov                            
              13      14      15    21    29    9                              
     WBC Types                                                                 
              1992    1992    1992  1992  1992  1992                           
     ______________________________________                                    
     Lymphocytes                                                               
              20      20      19    17    19    17                             
     Monocytes                                                                 
              12      13       9    14     7     8                             
     Eosinophils                                                               
              --      --       5    --    --    --                             
     Basophils                                                                 
              --      --      --    --    --    --                             
     Neutrophils                                                               
              68      67      67    69    74    75                             
     ______________________________________                                    

Table 39 (below) shows various blood test results taken before, during, and at the end of the treatment with the plant extract. The first three columns represent tests taken before treatment, while the remaining columns represent tests taken after treatment. As the table shows, most of the blood cells increased as a result of the treatment and included the greatest increases generally during the middle of the treatment.

                TABLE 39                                                    
     ______________________________________                                    
              Oct.   Oct.     Oct. Oct.   Oct. Nov.                            
              13     14       15   21     29   9                               
     DATES    1992   1992     1992 1992   1992 1992                            
     ______________________________________                                    
     Blood                                                                     
     Cells                                                                     
     WBC      2.9    3.3      3.3  3.4    4.7  3.6                             
     RBC      4.31   4.34     4.24 4.29   4.35 4.41                            
     Hb       12.0   12.3     12.0 12.0   12.3 13.0                            
     HCT      38.1   38.3     37.5 37.3   37.8 39.4                            
     MCV      88.4   88.2     88.4 86.9   86.9 89.3                            
     MCH      27.8   28.3     28.3 28.0   28.3 29.5                            
     MCHC     31.5   32.1     32.0 32.2   32.5 33.0                            
     PLT      98     111      97   102    149  141                             
     LYM %    19.9   19.9     15.4 17.0   19.0 16.8                            
     MID %    12.4   13.5     --   13.7   7.3  8.2                             
     NEUT %   67.7   66.6     --   69.3   73.7 75.0                            
     LYM      0.6    0.7      0.5  0.6    0.9  0.6                             
     MID      0.4    0.4      --   0.5    0.3  0.3                             
     NEUT     1.9    2.2      --   2.3    3.5  2.7                             
     RDW-CV   15.0   14.1     15.1 14.3   14.4 15.5                            
     PDW      25.3   --       20.7 --     25.7 --                              
     MPV      13.5   --       13.7 --     13.6 --                              
     P-LCR    52.3   --       53.8 --     52.7 --                              
     ______________________________________                                    

Table 40 (below) describes the biochemical status of Subject No. 7. The first column reflects the test data from the subject prior to treatment with the plant extract. Columns two and three show the data from biochemical tests taken during and at the end of treatment, respectively. The fourth and fifth columns list the measurement units and the range of normal values, respectively. As shown in table 40, the data was within the range of normal values by the end of the treatment. Moreover, there was an overall increase in the data, with the exception of the triglycerides, creatinine, and calcium.

                TABLE 40                                                    
     ______________________________________                                    
               Oct     Oct     Nov                                             
     Biochemical                                                               
               15      29      9            Normal                             
     Tests     1992    1992    1992  Units  Values                             
     ______________________________________                                    
     Urea      47      36      52    mg/ml  15-55                              
     Cholesterol                                                               
               142     142     158   "      125-260                            
     HDL       24      24      30    "      30-65                              
     LDL       82      92      105   "       88-188                            
     Triglycerides                                                             
               210     207     116   "       40-160                            
     Creatinine                                                                
               1.2     1.2     1.1   "      0.9-1.5                            
     Calcium   9.7     8.9     9.2   "       8.1-10.4                          
     Phosphorus                                                                
               3.9     4.0     4.1   "      2.5-4.5                            
     Magnesium 2.0     1.9     2.1   mEq/l  1.7-2.4                            
     ______________________________________                                    

Table 41 (below) shows changes in the blood electrolytes of Subject No. 7. All values are measured in mEq/l. The first column shows the results before treatment with the plant extract. The second and third columns represent the during and end of treatment, respectively. The fourth column shows the range of normal values. Subsequent to treatment, all data was within the normal range of values, except for the gamma-GT data. Moreover, there was an overall increase in the data for the sodium, trans-GO, trans-GP, and gamma-GT by the end of the treatment.

                TABLE 41                                                    
     ______________________________________                                    
                Oct    Oct        Nov                                          
                15     29         9    Normal                                  
     Electrolytes                                                              
                1992   1992       1992 Values                                  
     ______________________________________                                    
     K          5.6    4.3        4.2  3.5-5.1                                 
     Na         108    140        138  136-146                                 
     Cl         102    101        101   98-107                                 
     Trans-GO   27     28         28    5-40                                   
     Trans-GP   17     27         22    5-40                                   
     .gamma.-GT 48     20         61   10-50                                   
     Alp        97     88         86    30-125                                 
     ______________________________________                                    

Table 42 (below) shows the results of protein electrophoresis. The first column shows the results prior to treatment with the plant extract. The second column shows the results during the treatment and the third column shows the results at the end of the treatment. The fourth column shows the range of normal values. As the table indicates, the data was within the range of normal values. Furthermore, there was an overall increase in the albumins, a1 data, a2 data, beta data, and albumin/globulin ratio.

                TABLE 42                                                    
     ______________________________________                                    
                  Oct    Oct       NOV                                         
     Protein      15     29        9    Normal                                 
     Electrophoresis                                                           
                  1992   1992      1992 Values                                 
     ______________________________________                                    
     Albumins     59.4   61.2      59.9 52-65                                  
     a1           2.5    2.4       2.8    2-4.8                                
     a2           11.0   11.5      11.1 11-15                                  
     .beta.       11.1   10.8      12.2  6-13                                  
     .gamma.      16.0   14.1      14   10-19                                  
     Alb/Glob     1.46   1.58      1.49                                        
     ______________________________________                                    
SUBJECT NO. 8

Subject No. 8 was not taking any AZT or DDI but was ingesting some herbal remedies such as, for example, gingseng. Subject No. 8 was treated from Oct. 21, 1992 to Nov. 16, 1992. Blood for the Oct. 21, 1992 tests was taken prior to treatment and blood for the Nov. 11, 1992 tests was taken after treatment. The same tests were performed on Subject No. 8 as on the previous subjects. The units for measurement, as well as the standard values, are the same with Subject No. 8 as for the previous subjects.

Table No. 43 (below) shows the results of the HIV-AG and T-Cell tests. Subject No. 8 tested negative for HIV-AG before and after treatment. The T4 cells increased significantly due to treatment.

                TABLE 43                                                    
     ______________________________________                                    
               OCT                  NOV                                        
               21            NOV    16                                         
     HIV-AG    1992          3      1992                                       
     T-CELLS   NEGATIVE      1992   NEGATIVE                                   
     ______________________________________                                    
     ANL %     56            49     48                                         
     ANL       2360          --     2400                                       
     T3%       83            86     79                                         
     T3        1900          --     1896                                       
     T4%       25            36     31                                         
     T4        575           --     744                                        
     T8%       53            48     47                                         
     T8        1219          --     1128                                       
     ______________________________________                                    

Table 44 (below) represents specific changes in the white blood cell types prior to treatment with the plant extract. The first three columns reflect the test results before treatment. The next four columns represent the changes in the White blood cells during treatment. As shown in the table, the neutrophils increased while the lymphocytes and monocytes remained approximately the same.

                TABLE 44                                                    
     ______________________________________                                    
              Oct 19  Oct 21  Oct 26                                           
                                    Nov 3 Nov 12                               
                                                Nov 16                         
     WBC TYPES                                                                 
              1992    1992    1992  1992  1992  1992                           
     ______________________________________                                    
     Lymphocytes                                                               
              51      56      28    45    49    48                             
     Monocytes                                                                 
              10      12      5     11     9     8                             
     Eosinophils                                                               
              --      --      2     --    --    --                             
     Basophils                                                                 
              --      --      --    --    --    --                             
     Neutrophils                                                               
              39      32      5     44    42    44                             
     ______________________________________                                    

Table 45 (below) shows various blood test results taken before, during, and at the end of the treatment with the plant extract. The first three columns represent tests taken before treatment. Columns four to six represent tests taken after treatment. As shown in the table, there was an overall increase in the RBC, HNb, HCT, PLT, NEUT%, and NEUT data, with the most significant increases often being during days 10-20 of treatment. Likewise, the data for the MCV, MCH. MCHC, MID%, LYM, and MID remained approximately the same but did include increases during days 10-20 of treatment. Furthermore, there was a decrease in the LYM% and RDW-CV data.

                TABLE 45                                                    
     ______________________________________                                    
            Oct  Oct      Oct    Nov    Nov  Nov                               
            19   21       26     3      9    16                                
            1992 1992     1992   1992   1992 1992                              
     ______________________________________                                    
     Blood                                                                     
     Cells                                                                     
     WBC      4.8    4.2      7.1  4.5    5.9  5.0                             
     RBC      6.48   6.47     6.54 6.19   6.57 6.61                            
     HNb      12.5   12.7     12.7 12.3   13.0 12.9                            
     HCT      39.7   39.5     39.7 37.6   39.6 40.1                            
     MCV      61.3   61.1     60.7 60.7   60.3 60.7                            
     MCH      19.4   19.9     19.4 19.9   19.8 19.5                            
     MCHC     31.5   32.2     32.0 32.7   32.8 32.2                            
     PLT      259    251      265  321    346  282                             
     LYM %    51.2   55.6     28.2 45.3   48.6 48.3                            
     MID %    10.5   12.0     7.9  11.1   9.3  8.1                             
     NEUT %   38.3   32.4     63.9 43.6   42.1 43.6                            
     LYM      2.5    2.3      2.0  2.0    2.9  2.4                             
     MID      0.5    0.5      0.5  0.5    0.5  0.4                             
     NEUT     1.8    1.4      2.0  2.0    2.5  2.2                             
     RDW-CV   16.8   16.7     15.1 15.1   15.0 15.6                            
     PDW      --     --       --   --     --   --                              
     MPV      --     --       --   --     --   --                              
     P-LCR    --     --       --   --     --   --                              
     ______________________________________                                    

Table 46 (below) shows the biochemical status of Subject No. 8. The first column represents the status of the subject prior to treatment with the plant extract. Columns two and three show data from the biochemical tests during and at the end of treatment, respectively. The fourth and fifth columns reflect the measurement units and the range of normal values, respectively. As the table shows, most of the data was within the range of normal values at the end of treatment, except for the HDL and triglycerides data which were slightly outside of the range. In addition, increases were reflected in the data for cholesterol, LDL, triglycerides, calcium, and phosphorus.

                TABLE 46                                                    
     ______________________________________                                    
     Biochemical                                                               
             Oct 21   Nov 3    Nov 16        Normal                            
     Tests   1992     1992     1992   Units  Values                            
     ______________________________________                                    
     Urea     48      40        36    mg/100 ml                                
                                             15-55                             
     Cholesterol                                                               
             141      113      182           125-260                           
     HDL      32      17        28    "      30-65                             
     LDL     112      78       126    "       88-188                           
     Triglycerides                                                             
             135      118      161    "       40-160                           
     Creatinine                                                                
             1.5      1.0      1.4    "      0.9-1.5                           
     Calcium 9.4      9.6      9.7    "       8.1-10.4                         
     Phosphorus                                                                
             3.5      3.6      3.8    "      2.5-4.5                           
     Magnesium                                                                 
              2       2.1      2.0    mEq/l  1.7-2.4                           
     ______________________________________                                    

Table 47 (below) shows changes in the blood electrolytes of Subject No. 8. All values were measured in mEq/l. In the first column, the data reflects results before treatment with the plant extract. The second and third columns represent during and the end of treatment, respectively. The fourth column reflects the range of normal values. As the table indicates, all the data is within the range of normal values by the end of the treatment. Moreover, there is an increase in the sodium, chlorine, and alp electrolytes.

                TABLE 47                                                    
     ______________________________________                                    
     Electrolytes                                                              
             Oct 21 1992                                                       
                       Nov 3 1992                                              
                                 Nov 16 1992                                   
                                         Normal Values                         
     ______________________________________                                    
     K       4.4       4.5       4.3     3.5-5.1                               
     Na      133       137       144     136-146                               
     Cl      100       102       103     98-107                                
     Trans-GO                                                                  
             23        19        22      5-40                                  
     Trans-GP                                                                  
             17        12        12      5-40                                  
     .gamma.-GT                                                                
             23        18        14      10-50                                 
     Alp     51        69        60      30-125                                
     ______________________________________                                    

Table 48 (below) represents the results of protein electrophoresis. The first column shows the results before treatment with the plant extract, the second column shows the results during treatment, and the third column shows the results at the end of treatment. The fourth column shows the range of normal values. As shown in the table, most of the data shows an overall decrease by the end of treatment, except for the beta and alp data. However, a majority of the data (a1, a2, gamma, and alp) show a significant increase during days 10-20 of the treatment. By the end of treatment, data for a1, a2, and gamma are not within the range of normal values.

                TABLE 48                                                    
     ______________________________________                                    
     Protein                              Normal                               
     Electrophoresis                                                           
              Oct 21 1992                                                      
                        Nov 3 1992                                             
                                  Nov 16 1992                                  
                                          Values                               
     ______________________________________                                    
     Albubines                                                                 
              54.8      50        53.6    52-65                                
     a1       1.6       2.5       1.8       2-4.5                              
     a2       6.8       9.6       7.0     11-15                                
     .beta.   9.3       9.4       11.0     6-13                                
     .gamma.  27.5      28.5      26.6    10-19                                
     Alb/Glob 1.21      1.00      1.16    --                                   
     Alp      51        69        60       30-125                              
     ______________________________________                                    
SUBJECT NO. 9

Subject No. 9 was HIV positive and asymptomatic. Subject No. 9 was infected by the virus in 1982 and was taking AZT prior to treatment with the plant extract. Subject No. 9 was treated from Oct. 21, 1992 to Nov. 9, 1992. Blood for the Oct. 21, 1992 test was taken prior to treatment and blood for the Nov. 9, 1992 test was taken after treatment. The same tests were performed on Subject No. 9 as were performed on the previous subjects. The units for measurement, as well as the standard values, are the same as with the previous subjects.

Table 49 (below) shows the results of the HIV-AG and T-Cell tests. Subject No. 9 tested negative for HIV-AG before and after treatment with the plant extract. Moreover, the T-3 and T-8 cells increased due to the treatment.

                TABLE 49                                                    
     ______________________________________                                    
     HIV          Oct 21 1992                                                  
                            Nov 9 1992                                         
     T-Cells      Negative  Negative                                           
     ______________________________________                                    
     ANL %        27        42                                                 
     ANL          1539      2184                                               
     T3 %         80        92                                                 
     T3           1231      2009                                               
     T4 %         24        26                                                 
     T4           370       567                                                
     T8 %         52        63                                                 
     T8           800       1375                                               
     ______________________________________                                    

Table 50 (below) represents specific changes in the white blood cell types before treatment with the plant extract. The first two columns show the test results before treatment. The next two columns represent the changes in white blood cells during treatment. As shown in the table, the lymphocytes increased while the monocytes and neutrophils decreased. Moreover, the highest increases occurred during days 10-20 of treatment.

                TABLE 50                                                    
     ______________________________________                                    
     WBC TYPES                                                                 
              Oct 19 1992                                                      
                        Oct 21 1992                                            
                                  Nov 5 1992                                   
                                          Nov 9 1992                           
     ______________________________________                                    
     Lymphocytes                                                               
              32        27        46      42                                   
     Monocytes                                                                 
               5         6         3       2                                   
     Eosinophils                                                               
               2         2        --       1                                   
     Basophils                                                                 
              --        --        --      --                                   
     Neutrophils                                                               
              61        65        51      55                                   
     ______________________________________                                    

Table 51 (below) shows various blood tests taken before, during, and at the end of the treatment with the plant extract. The first two columns represent tests taken before treatment. The next two columns represent tests taken after treatment. As shown in the table, most of the blood cell types increased (WBC, RBC, Hb, CT, MCV, MCH, MCHC, PLT, LYM%, LYM), with the highest increases falling within the 10-20 day period of treatment. The data for the PDW, MP, P-LCR remained substantially the same but included large increases during days 10-20 of treatment. Other data included RDW-CV which remained generally unchanged and the MID%, NEUT%, MID, and NEUT data which showed decreases.

                TABLE 51                                                    
     ______________________________________                                    
     Blood Cells                                                               
              Oct 19 1992                                                      
                        Oct 21 1992                                            
                                  Nov 5 1992                                   
                                          Nov 9 1992                           
     ______________________________________                                    
     WBC      5.5       5.7       6.6     5.2                                  
     RBC      4.79      4.64      5.21    5.08                                 
     Hb       14.9      14.8      16.7    17.3                                 
     CT       44.9      43.6      49.4    48.3                                 
     MCV      93.7      94.0      94.8    95.1                                 
     MCH      31.1      31.9      32.1    34.1                                 
     MCHC     33.2      33.9      33.8    35.8                                 
     PLT      180       188       188     192                                  
     LYM %    32.9      27.8      46.5    42.2                                 
     MID %    8.2       9.3       3.0     4.5                                  
     NEUT %   58.9      62.9      50.5    53.3                                 
     LYM      1.8       1.6       3.1     2.2                                  
     MID      0.5       0.5       0.2     0.2                                  
     NEUT     3.2       3.6       3.3     2.8                                  
     RDW-CV   11.7      12.0      11.6    11.7                                 
     PDW      14.1      13.2      15.7    13.5                                 
     MP       11.2      10.7      11.4    10.7                                 
     P-LCR    34.9      31.6      35.8    31.5                                 
     ______________________________________                                    

Table 52 (below) describes the biochemical status of Subject No. 9. The first column represents the status of the subject prior to treatment with the plant extract. The second column shows the data from the biochemical tests at the end of treatment. The third and fourth columns list the measurement units and the range of normal values, respectively. As shown in the table, all of the data is within the range of normal values, with the exception of the triglycerides. There was an increase in the cholesterol, HDL, LDL, and triglycerides.

                TABLE 52                                                    
     ______________________________________                                    
     Biochemical                          Normal                               
     Tests    Oct 21 1992                                                      
                        Nov 9 1992                                             
                                  Units   Values                               
     ______________________________________                                    
     Urea      23        22       mg/100 ml                                    
                                          15-55                                
     Cholesterol                                                               
              152       200       "       125-260                              
     HDL       35        41       "       30-65                                
     LDL      110       125       "        88-188                              
     Triglycerides                                                             
              164       170       "        40-160                              
     Creatinine                                                                
              1.0       1.0       "       0.9-1.5                              
     Calcium  9.7       9.2       "        8.1-10.4                            
     Phosphorus                                                                
              4.0       3.8       "       2.5-4.5                              
     Magnesium                                                                 
              2.1       2.0       mEq/l   1.7-2.4                              
     ______________________________________                                    

Table 53 (below) shows changes in the blood electrolytes of Subject No. 9. All values were measured in mEq/l. The first column shows the results before treatment with the plant extract. The second column represents the results by the end of treatment. The third column shows the range of normal values. As the table shows, all the data was within the range of normal values. Moreover, there was an increase in the potassium, sodium, trans-GO, trans-GP, and gamma-GT data. The chlorine data remained the same and the alp data decreased.

                TABLE 53                                                    
     ______________________________________                                    
     Electrolytes                                                              
               Oct 21 1992 Nov 9 1992                                          
                                     Normal Values                             
     ______________________________________                                    
     K         4.3         4.5       3.5-5.1                                   
     Na        136         141       136-146                                   
     Cl        103         103       98-107                                    
     Trans-GO  19          21        5-40                                      
     Trans-GP  10          18        5-40                                      
     .gamma.-GT                                                                
               16          30        10-50                                     
     Alp       46          37        30-125                                    
     ______________________________________                                    

Table 54 (below) shows the results of protein electrophoresis. The first column shows the results prior to treatment with the plant extract. The second column shows the results at the end of the treatment. The third column shows the range of normal values. As shown in table 54, the data is within the range of normal values, except for the a2 and gamma data. Moreover, there were increases in the data for alb, beta, and the alb/glob ratio.

                TABLE 54                                                    
     ______________________________________                                    
     Protein Electrophoresis                                                   
                 Oct 21 1992                                                   
                            Nov 9 1992 Normal Values                           
     ______________________________________                                    
     Alb         55.7       58.3       52.65                                   
     a1          3.7        3.1          2-4.5                                 
     a2          11.6       10.1       11-15                                   
     .beta.      9.4        9.9         6-13                                   
     .gamma.     19.6       18.6       10-19                                   
     Alb/Glob    1.26       1.40                                               
     ______________________________________                                    

It will now be appreciated that the present invention provides a method for treating HIV positive subjects. The method apparently destroys, neutralizes or at least inhibits the HIV virus. This is evidenced by the fact that the p24 antigen is substantially destroyed or reduced by administering an effective amount of our therapeutically active composition to a subject. The composition used in the method has a medicinal application and results in a negative reading for the p24 (HIV) antigen in a subject that initially tested positive for the p24 (HIV) antigen. Alternatively, the composition used in the method maintains a negative reading for the p24 (HIV) antigen in a subject that initially tested negative for the p24 (HIV) antigen. The composition used in the inventive method includes as an active pharmaceutical an extract of a Mediterranean and West Asiatic plant known as Asphodelus tenuifolius.

As the data from the nine HIV positive subjects demonstrates, the administration of the Asphodelus tenuifolius plant extract to HIV positive subjects resulted in negative readings for the p24 antigen in those subjects that initially tested positive for the antigen and also maintained negative readings for the p24 antigen in those subjects that initially tested negative for the antigen. Furthermore, the administration of the plant extract to the subjects increased the number of WBC-PMN, lymphocytes, monocytes, platelets, and erythrocytes, especially between 10-20 days of treatment with the plant extract. Moreover, in many instances, the subclasses of T-Cells increased, particularly between 10-20 days of treatment.

In addition to the foregoing, toxicity studies support the conclusion of the plant extracts' non-toxicity.

Therefore, it should be recognized that, while the invention has been described in relation to a preferred embodiment thereof, those skilled in the art may develop a wide variation of structural details without departing from the principles of the invention. Accordingly, the appended claims are to be construed to cover all equivalents falling within the true scope and spirit of the invention.

Claims

1. A composition for treating an HIV positive subject, having more than 40 picograms/ml of P24 (HIV) antigen comprising a mixture of an aqueous extract of an Asphodelus tenuifolius herb, cortisone and a pharmaceutically acceptable carrier.

2. The composition of claim 1 wherein the cortisone is a methylhydrocortisone.

3. A method of treating an HIV positive subject having a P24 (HIV) antigen of more than 40 picograms/ml to lower the P24 (HIV) antigen to not more than 40 picograms/ml which comprises administering to said HIV positive subject, a composition comprising an aqueous extract of at least one plant of Asphodelus tenuifolius and a pharmaceutically acceptable carrier.

4. The method of claim 3 wherein said composition also contains a cortisone.

5. The method of claim 4 wherein the cortisone is a methylhydrocortisone.

6. The method of claim 3 wherein said aqueous extract is prepared by adding about 40 to about 60 grams of Asphodelus tenuifolius plants to about 1.5 liters to about 2.5 liters of water, boiling the resulting mixture for about 15 to 25 minutes, filtering and recovering said aqueous extract.

7. The method of claim 6 wherein said composition also contains cortisone.

8. The method of claim 7 wherein the cortisone is a methylhydrocortisone.

9. The method of claim 6 wherein said composition also contains cortisone.

10. The method of claim 9 wherein the cortisone is a methylhydrocortisone.

11. A method of treating an HIV positive subject a P24 (HIV) antigen of more than 40 picograms to lower the P24 (HIV) antigen to not more than 40 picograms which comprises administering to said subject, a composition having an aqueous extract of at least one Asphodelus tenuifolius plant and a pharmaceutically acceptable carrier.

12. The method of claim 11 wherein said aqueous extract is prepared by adding about 40 to about 60 grams of an Asphodelus tenuifolius plant to about 1.5 liters to about 2.5 liters of water, boiling the resulting mixture for about 15 to 25 minutes, filtering and recovering said aqueous extract.

13. The method of claim 11 wherein said composition also contains cortisone.

14. The method of claim 13 wherein said composition also contains cortisone.

Referenced Cited
U.S. Patent Documents
40189 October 1863 Scott
43118 June 1864 Knoebel
65302 May 1867 Thurmon
117338 July 1871 Simmons
132233 October 1872 Barnes
135083 February 1873 Geomen
4518591 May 21, 1985 Iida
4716120 December 29, 1987 Tsay
5002938 March 26, 1991 Wang et al.
Other references
  • Nene et al., Labder. J. Sci. Tech B, vol. 6, pp. 226-228, (1968).fwdarw.Abstract Only see search report. Saxena et al., Curr. Sci, vol. 44(19), p. 723, (1975).fwdarw.Abstract Only see search report. Abdel-Gawad et al., Fitoterapia, vol. 47, p. 111, (1976).fwdarw.Abstract Only see search report. Fell et al. J. Pharm. Pharmacol., vol. 20, pp. 646-649, (1968).fwdarw.Abstract only see search report. Greene, Scientific American, pp. 90-105, (Sep. 93). Fauci, Science, vol. 262, pp. 1011-1018, (12 Nov. 93). Bonsignore et al., Fitoterapia, vol. 61/4, pp. 339-341, (1990).fwdarw.Abstract Only see search report. Dafni et al., J. Ethnopharmacol., vol. 10, pp. 295-310, (1984).fwdarw.Abstract Only see search report. Singh et al., Indian J. Chem, vol. 12 (12), pp. 1325-1237, (1974).fwdarw.Abstract Only see search report. Hamanouda et al., Chem. and Pharm. Studies A. Microcarpas, PLMEAA 22(2):109-212, 1972. King J. American Dispensatory 8th Ed Cincinnati 1870 pp. 965-967. Steinmentz E. F. Codey Vegetabilis 1951 Amsterdam #161. Bailey, Standard Cyclopedia of Horticulture, Macmillan Co., New York, 1935. Chittenden, Dictionary of Gardening, Clarendon Press, Oxford. Fell et al. J. Pharm. Pharmac. 20:646-649 (1968). Hommouda et al., Chemical and Pharmacological Studies of Asphodelus Microcarpus, PLMEAA 22(2) 109-212 (1972). Hammouda et al., Die Pharmazie, Pharmazie 29, H. 9 (1974). Madaan et al., Indian Journal of Biochemistry & Biophysics vol. 10, Mar. 1973, pp. 55-58. Scarborough, Clinics in Plastic Surgery, vol. 10/Nov. 4, Oct., 1983. R.M.T. Dahlgren, et al., The Families of Monocotyledons-Struc Evolution and Taxonomy, Springer-Verlag, New York, (1985). Aids and the Election, Scientific American, vol. 259, No. 4, p. 14 (1988). AIDS: an Unknown Distance Still to Go, Scientific American, vol. 259, No. 4, p. 152 (1988). AIDS IN, Scientific American, vol. 259, No. 4, p. 40 (1988). The Molecular Biology of the AIDS VIRUS, Scientific American, Vol. 259, No. 4, pp. 52 (1988). The Origins of the AIDS Virus, Scientific American, vol. 259, No. 4, p. 90 (1988). HIV Infection: the Clinical Picture, Scientific American, vol. 259, No. 4, p. 90 (1988). HIV Infection: the Cellular Picture, Scientific American, vol. 259, No. 4, p. 100 (1988). AIDS Therapies, Scientific American,, vol. 259, No. 4, p. 110 (1988). AIDS Vaccines, Scientific American, vol. 259, No. 4, p. 120 (1988). The Epidemiology of AIDS in the U.S., Scientific American, vol. 259, No. 4, p. 72 (1988). The Social Dimension of AIDS, Scientific American, vol. 259, No. 4, p. 128 (1988). The International Epidemiology of AIDS, Scientific American, vol. 259, No. 4, p. 82 (1988).
Patent History
Patent number: 5667783
Type: Grant
Filed: Dec 13, 1993
Date of Patent: Sep 16, 1997
Assignees: Constantine Alen (Chicago, IL), Polexene Alen (Chicago, IL)
Inventor: Stavros Papadakis (Chicago, IL)
Primary Examiner: John Kight
Assistant Examiner: Howard C. Lee
Law Firm: Laff, Whitesel, Conte & Saret, Ltd.
Application Number: 8/165,270
Classifications
Current U.S. Class: 424/1951; Plant Extract Or Plant Material Of Undetermined Constitution (514/783); Virus (514/934)
International Classification: A61K 3578;